TABLE 1.
Demographics of cohorts used for current analyses
| VICTORY Consortium |
GETAID cohort |
||||
|---|---|---|---|---|---|
| GEMINI 2 (n = 814) | Entire cohort (n = 659) | Included cohort (n = 501) | Entire cohort (n = 173) | Included cohort (n = 55) | |
| Female sex, n (%) | 435 (53) | 381 (58) | 280 (56) | 109 (63) | 34 (62) |
| Mean age, y (SD) | 35.5 (11.9) | 40 (15.4) | 39 (15.7) | 37.3 (11.8) | 36.4 (10.8) |
| Mean BMI, kg/m2 (SD) | 24.0 (6.0) | 25.5 (6.9) | 25.3 (6.9) | 20.9 (3.9) | 20.2 (3.5) |
| Mean disease duration, y (SD) | 9.1 (7.5) | 14.2 (11.2) | 13.7 (11.1) | 12.2 (7.6) | 13.2 (8.8) |
| Prior TNFα-antagonist exposure, n (%) | 535 (66) | 598 (91) | 452 (90) | 172 (99) | 55 (100) |
| Prior TNFα-antagonist failure, n (%) | 497 (61) | 497 (75) | 379 (76) | 134 (78) | 41 (75) |
| Median CRP, mg/L (IQR) | 10.6 (4.5–31.6) | 4.7 (1–16.9) | 4.4 (1–16.9) | 18.4 (8.0–45.0) | 33 (8.0–50.0) |
| Mean albumin, g/L (SD) | 34.9 (5.7) | 38.7 (5.4) | 38.4 (5.6) | 31.4 (7.6) | 30.2 (6.8) |
| Disease location, n (%) | |||||
| Ileum only | 141 (17) | 104 (16) | 74 (15) | 31 (18) | 10 (18) |
| Colon only | 230 (28) | 138 (21) | 105 (21) | 37 (21) | 16 (29) |
| Ileocolonic | 443 (54) | 413 (63) | 318 (63) | 94 (54) | 29 (53) |
| Prior surgery for CD, n (%) | 355 (44) | 400 (61) | 293 (59) | 84 (49) | 27 (49) |
| Prior fistulising disease, n (%) | 297 (36) | 240 (36) | 178 (36) | 57 (33) | 20 (36) |
Note: Patients were excluded from the VICTORY and GETAID cohorts for not having baseline laboratory test values (CRP or albumin) to calculate the CDST. Patients in the VICTORY consortium were classified as follows: high-probability group (n = 131), intermediate-probability group (n = 281), low-probability group (n = 89). Patients in the GETAID cohort were classified as follows: high-probability group (n = 3); intermediate-probability group (n = 24); low-probability group (n = 28). Because of the small sample size of the high-probability group in GETAID (a highly refractory population early in the period during which vedolizumab became available), it was combined with the intermediate-probability group for analyses.